Zydus Life gains after receiving USFDA nod for Chlorpromazine Hydrochloride Injection

Zydus Lifesciences added 2.36% to Rs 991.55 after the company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Chlorpromazine Hydrochloride Injection.

The said drug is equivalent to the reference listed drug (RLD), Thorazine Injection. Chlorpromazine Hydrochloride Injection is used to treat certain mental/mood disorders (such as schizophrenia, psychotic disorders, manic phase of bipolar disorder, severe behavioral problems in children). It is also used to control nausea/vomiting, relieve prolonged hiccups, relieve restlessness/anxiety before surgery, treat a certain liver problem (porphyria), and help treat tetanus.

The drug will be manufactured at the groups injectable manufacturing facility at Jarod, near Vadodara, Gujarat (India).

Chlorpromazine Hydrochloride Injection had annual sales of $ 12.5 million in the United States (IQVIA MAT Jan24).

Meanwhile, the company has received tentative approval from the USFDA to manufacture and market Edaravone Injection.

The said drug is equivalent to reference listed drug, Radicava. Edaravone is used to treat a certain type of nerve disease called amyotrophic lateral sclerosis (ALS, also commonly called Lou Gehrig's disease). The drug will be manufactured at the groups injectable manufacturing facility at Jarod, near Vadodara (India).

Edaravone Injection had annual sales of $ 19 million in the United States (IQVIA MAT Jan-24).

The group now has 391 approvals and as of 31 December 2023 the firm has so far filed over 460 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The pharmaceutical company reported 26.76% increase in consolidated net profit of Rs 789.6 crore on 5.83% rise in revenue from operations to Rs 4,343.70 crore in Q3 FY24 over Q3 FY23.

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